HealthyPhase 1NCT06807762
Safety and Pharmacokinetics of Extrato de Cannabis Sativa GreenCare
A Phase 1 study testing Cannabis oil in people with Healthy, run by GreenCare Pharma at 1 site in Brazil.
Trial summary
The goal of this Phase I clinical trial is to assess the pharmacokinetic availability and safety and tolerability profile of Extrato de Cannabis sativa GreenCare 79.14 mg/mL. The main question it aims to answer is: Is the Extrato de Cannabis sativa GreenCare 79,14 mg/mL safe? Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cannabis oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- 18 Mar 2025to Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women from 18 to 65 years, inclusive;
- Body weight ≥ 50 kg and BMI between 18.5 and 30 kg/m2, inclusive;
- Be healthy according to medical history, i.e., have laboratory test results within normal ranges and/or any deviations from normal classified as clinically insignificant;
- Be exclusively participating in this clinical study during the research period;
- Understand and comply with the protocol requirements and consent to participate in the study by signing the Informed Consent Form (ICF) approved by an Ethics Committee (EC).
Who cannot join
- Having participated in any experimental study or ingested any experimental drug within 1 (one) year prior to the start of this study;
- Inability to use oral medication and/or cooperate with investigators due to cognitive impairment or mental state;
- Reported allergy to any component of Cannabis sativa extract 79.14 mg/mL;
- Personal or first-degree family history of schizophrenia, bipolar affective disorder, psychotic symptoms, suicidal ideation, planning and/or attempt, and/or severe uncontrolled psychiatric comorbidities, at the discretion of the principal investigator;
- Donated blood within four (4) months prior to signing the Informed Consent Form (ICF);
- Being pregnant, breastfeeding, intending to become pregnant during the study period, or having a positive result for urinary β-HCG testing;
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- Reported use of Cannabis and/or its derivatives for any purpose in the past 6 months;
- Personal history of Cannabis use disorder and/or other illicit drug use disorder;
- Personal history of alcohol, tobacco, opioid, benzodiazepine, barbiturate, and/or other substance use disorders, such as St. John's Wort;
- Smokers or ex-smokers who quit less than 6 months ago;
- Consumed alcoholic beverages within 24 hours before the study confinement period;
- Any condition that prevents participation at the discretion of the investigator;
- Dietary habits that prevent ingestion of the diet provided during the study;
- Any clinical or laboratory finding or therapy that, at the investigator's discretion, may place the participant at risk or interfere with study objectives or outcomes;
- Non-compliance with the complete ingestion of the diet provided - determination at the discretion of the responsible physician.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
GreenCare Pharma
Vinhedo, São Paulo, 13288006
Study coordinator, MsC PhD, +55 11 942562895, medical@greencarepharma.com.br
Fernando Pacheco, MD
About this study
Official title: Phase I Clinical Trial to Assess Tolerability, Safety, and Pharmacokinetics of Extrato de Cannabis Sativa GreenCare 79.14 mg/mL - Drops Solution - in Healthy Research Participants of Both Sexes in a Fed State
The goal of this Phase I clinical trial is to assess the pharmacokinetic availability and safety and tolerability profile of Extrato de Cannabis sativa GreenCare 79.14 mg/mL. The main question it aims to answer is:
- Is the Extrato de Cannabis sativa GreenCare 79,14 mg/mL safe?
- Conditions
- Healthy
- Being tested
- Cannabis oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabis oilDrug
Also called Extrato de Cannabis sativa GreenCare 79.14 mg/mL
Healthy subjects will be treated with a solution of Cannabis sativa extract diluted in MCT oil, at doses ranging from 39.62 mg to 791.4 mg. This protocol will be divided into two stages:
Stage 1 - Determination of the Maximum Tolerated Dose (MTD): Participants (n=60) will be dynamically randomized and will receive Cannabis sativa extract (GreenCare, 79.14 mg/mL) as a single dose after breakfast, with doses ranging from 39.62 mg to 791.4 mg.
Stage 2 - Assessment of the MTD: All participants (n=12) will receive the MTD determined in Stage 1, administered in two daily doses for 14 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Extrato de Cannabis sativa GreenCare 79.14 mg/mL | Experimental | Concentration unit: 79.14 mg/mL Receives: Drug: Cannabis oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the Maximum Tolerated Dose (MTD) of Cannabis sativa Extract GreenCare 79,14 mg/mL
Measured: Up to 5 days
Secondary outcomes (2)
Frequency, intensity, and severity of adverse events
Measured: Up to 5 days
Plasma concentrations of CBD and THC
Measured: Up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start18 Mar 2025
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GreenCare Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fernando Pacheco, MD, Principal investigator, Synvia Clinical | CAEP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807762
- Sponsor's protocol ID
- GreenCare-ExtratoCannabis-0124
- Other IDs
- 131.001.23
- Status last verified
- Mar 2025
- First submitted
- 17 Jan 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial to Assess Tolerability, Safety, and Pharmacokinetics of Extrato de Cannabis Sativa GreenCare 79.14 mg/mL - Drops Solution - in Healthy Research Participants of Both Sexes in a Fed State
- ClinicalTrials.gov ID
- NCT06807762
- Acronym / sponsor ID
- GreenCare-ExtratoCannabis-0124
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- GreenCare PharmaIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this Phase I clinical trial is to assess the pharmacokinetic availability and safety and tolerability profile of Extrato de Cannabis sativa GreenCare 79.14 mg/mL. The main question it aims to answer is:
- Is the Extrato de Cannabis sativa GreenCare 79,14 mg/mL safe?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extrato de Cannabis sativa GreenCare 79.14 mg/mL | Experimental | Drug: Cannabis oilConcentration unit: 79.14 mg/mL |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women from 18 to 65 years, inclusive;
- Body weight ≥ 50 kg and BMI between 18.5 and 30 kg/m2, inclusive;
- Be healthy according to medical history, i.e., have laboratory test results within normal ranges and/or any deviations from normal classified as clinically insignificant;
- Be exclusively participating in this clinical study during the research period;
- Understand and comply with the protocol requirements and consent to participate in the study by signing the Informed Consent Form (ICF) approved by an Ethics Committee (EC).
Key exclusion criteria (15 listed)
- Having participated in any experimental study or ingested any experimental drug within 1 (one) year prior to the start of this study;
- Inability to use oral medication and/or cooperate with investigators due to cognitive impairment or mental state;
- Reported allergy to any component of Cannabis sativa extract 79.14 mg/mL;
- Personal or first-degree family history of schizophrenia, bipolar affective disorder, psychotic symptoms, suicidal ideation, planning and/or attempt, and/or severe uncontrolled psychiatric comorbidities, at the discretion of the principal investigator;
- Donated blood within four (4) months prior to signing the Informed Consent Form (ICF);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabis oilAlso: Extrato de Cannabis sativa GreenCare 79.14 mg/mLHealthy subjects will be treated with a solution of Cannabis sativa extract diluted in MCT oil, at doses ranging from 39.62 mg to 791.4 mg. This protocol will be divided into two stages: Stage 1 - Determination of the Maximum Tolerated Dose (MTD): Participants (n=60) will be dynamically randomized and will receive Cannabis sativa extract (GreenCare, 79.14 mg/mL) as a single dose after breakfast, with doses ranging from 39.62 mg to 791.4 mg. Stage 2 - Assessment of the MTD: All participants (n=12) will receive the MTD determined in Stage 1, administered in two daily doses for 14 consecutive days. | Drug | Extrato de Cannabis sativa GreenCare 79.14 mg/mL |
Primary outcome
Identification of the Maximum Tolerated Dose (MTD) of Cannabis sativa Extract GreenCare 79,14 mg/mL
Time frame: Up to 5 days
2 secondary outcomes
Frequency, intensity, and severity of adverse events
Time frame: Up to 5 days
Plasma concentrations of CBD and THC
Time frame: Up to 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fernando Pacheco, MD principal investigator
Synvia Clinical | CAEP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cannabis oil in people with Healthy, run by GreenCare Pharma at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabio Furtado (+5511942562895, fabio.furtado@greencarepharma.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of the Maximum Tolerated Dose (MTD) of Cannabis sativa Extract GreenCare 79,14 mg/mL (time frame: Up to 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.